Regulation (EU) 536/2014 and the role of ethics committees: a proposal for a review system model.

Independent ethics committees play an important role in clinical trials as well as in all health-related research. Internationally, the national laws of the individual countries have guided their local development and organisation over the decades. Directive 2001/20/EC of the European Parliament and of the Council explicitly recognised the ethics committees' duty to protect the rights, safety and well-being of human subjects involved in trials and to provide public assurance of that protection. Regulation (EU) 536/2014, which repealed the aforesaid directive, provides that a clinical trial must be subjected to scientific and ethical review, without specifically defining what they consist in. The divide between the evaluation of the ethical value and the scientific value of a study is very faint and, for some, it may even appear a meaningless distinction. While Regulation (EU) 536/2014 requires Member States to ensure that ethics committees are involved in the assessment process within their national territory, it does not require such ethical assessment to be binding. This article proposes a possible system for interaction between ethics committees and local regulatory authorities in which the meaning and purpose of the ethical assessment are conceptually clearly defined and not narrow.